MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. AIR FILTER

Model Number	MAJ-823
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the air filter had water enter during reprocessing.There was no patient harm associated with the event.The device was evaluated, and it was found that it is unclear what kind of water was entering via the leaking check valve, which could of affected reprocess ability.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.There was an additional finding of water entering via the leaking check valve, which could have affected reprocess ability.There are no additional findings.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the water in the air filter could not be concluded although it can presumed that water vapor in the air condensed inside the air filter.Olympus will continue to monitor field performance for this device.

• Brand Name: AIR FILTER
• Common Device Name: AIR FILTER
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17610637
• Report Number: 9610595-2023-12134
• Device Sequence Number: 6422264
• Product Code: FEB
• UDI-Device Identifier: 04953170069475
• UDI-Public: 04953170069475
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-823
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown